Reliance Life Sciences gets approval for COVID-19 vaccine trial
Reliance Life Sciences, part of Mukesh Ambani-led Reliance Industries Limited, on Thursday received regulatory approval to carry out clinical trials of its coronavirus vaccine candidate, reported The Economic Times. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) reviewed its application at a meeting yesterday and recommended it for approval. Here are more details.
Reliance Life Sciences aims to obtain reliable information on the vaccine's safety, tolerability, pharmacokinetics (how it reacts with living organisms), and mechanism of action of the drug so as to determine the maximum tolerable dose (MTD) with these trials. Phase-1 trials usually last for 58 days. "Once it is done, the company can approach for phase 2/3 trials," sources told the publication.
The vaccine by Reliance is a recombinant protein-based COVID-19 shot. The company had started the development process last year while the vaccine entered pre-clinical stage in October. It is being developed at the company's Navi Mumbai facility, and is expected to be launched by the first quarter of 2022. However, both Reliance and regulatory authorities are yet to issue a statement on the approval.
India has so far given regulatory approval to six coronavirus vaccines. They include Bharat Biotech's COVAXIN, Oxford-AstraZeneca's Covishield, Russia's Sputnik V, Moderna's vaccine, and the Johnson & Johnson shot. Most recently, Indian firm Zydus Cadila's COVID-19 vaccine was approved, making it the sixth vaccine to get the nod here and the first that can administered to the under-18 age group.
India began its coronavirus vaccination program this January and has since administered nearly 60 crore doses. Nearly 34% of Indians have received at least one vaccine shot while about 10% have been fully vaccinated. The Indian government has set a target to inoculate all adults (nearly one billion) by the end of this year.